Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1178-2016Class II

Pilling Modular Verres Body/Obturator, Product Code 140880

Teleflex Medical / initiated 2015-01-08 / Terminated / root cause: packaging

Teleflex Medical began a recall of Pilling Modular Verres Body/Obturator, Product Code 140880 on . FDA classified it as Class II and gives the reason as "Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1178-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
Product
Pilling Modular Verres Body/Obturator, Product Code 140880
Product code
GDM Needle, Aspiration And Injection, Reusable
Reason for recall
Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle tip).
Root cause tag
packaging
FDA root cause
Packaging process control
Action
Teleflex sent an Medical Device Advisory Notification letter dated January 8, 2016, to all affected customers notifying them of the packaging error. Our records indicate that you have received products that are subject to this notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at [email protected] or 1-866-246-6990.
Quantity in commerce
8
Distribution
US Distribution to the state of : UT
Product codes and lots
Lot K3

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1178-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1178-2016Class IITerminatedVoluntary: Firm initiated